510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860928Substantially Equivalent

Eyemeter

Indivisual Corporation, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860928 is the FDA 510(k) clearance record for EYEMETER, cleared for Indivisual Corporation, Inc. on . FDA records list one 510(k) clearance for Indivisual Corporation, Inc. As of , FDA records show no recalls naming K860928.

Clearance record

Decision date
Received
(24 days to decision)
Review panel
Unknown
Applicant
Indivisual Corporation, Inc. Counsel For Indivisual Corp., Los Angeles CA
Third party review
No